A Sub-Study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: vildagliptin (Drug); metformin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

Overall contact:
Novartis Pharmaceuticals, Phone: 862 778 8300

This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.

Official title: A Multicenter, Open-Label Sub-Study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin 100mg qd Plus Metformin 1000mg Bid in Drug Naive Patients With Type 2 Diabetes With Very Poor Glycemic Control

Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: glycosylated hemoglobin (HbA1c)at Baseline and week 24

Secondary outcome:

HbA1c at Baseline and week 12

Fasting plasma glucose test (FPG) at Baseline and week 24

Weight at baseline and week 24

Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks

Safety assessed by monitoring and recording all adverse events, serious adverse events.

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes

- Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry

- Body mass index 22-40 kg/meter squared

- HbA1c > 11% and/or FPG >270 mg/dL

Exclusion Criteria:

- Pregnant or lactating female

- History of type 1 diabetes

- Evidence of significant diabetic complications

- Treatment with insulin or any other oral antidiabetic agent

Other protocol-defined inclusion/exclusion criteria may apply.

Novartis Pharmaceuticals, Phone: 862 778 8300

Diabetes and Glandular Disease Research Associates, San Antonio, Texas 78229, United States; Recruiting
Sherwyn Schwartz, MD, Principal Investigator

Starting date: March 2007
Last updated: April 27, 2007